Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

October 4, 2023 updated by: London School of Hygiene and Tropical Medicine

Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on the pathogenesis of syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches using molecular tests allow the immune response of the patient to infection to be measured directly from a swab of a genital ulcer or rash and/or a blood sample and also allow the whole genetic sequence of the bacteria to be obtained from a swab.

In this study the investigators will collect swabs from ulcers or rashes and a blood sample from patients with syphilis and measure both the response of the patient immune system and the genetic sequence of the bacteria. Patients will be enrolled at sexual health clinics in the United Kingdom. Patients will receive standard medical care including standard treatment for syphilis in line with national guidelines. Standard management already includes collection of a swab and a blood sample. For this study an additional swab sample and an additional 5ml of blood will be collected for use in this research project. By better understanding host immune system responds to infection with syphilis the studies aims to gain better insights in to the pathogenesis of this important sexually transmitted disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1E 6JB
        • Mortimer Market Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Early infectious syphilis with exudative skin/genital lesions from which a lesion swab can be obtained

Description

Inclusion Criteria:

  • Early infectious syphilis with exudative skin/genital lesions from which a lesion swab can be obtained

Exclusion Criteria:

  • Age <18 years
  • Unable to provide consent
  • Patients with other stages of syphilis apart from Primary or Secondary OR patients without a lesion from which swabs can be obtained

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole Genome Sequencing
Time Frame: From samples collected at baseline
Whole Genome Sequencing of T.pallidum
From samples collected at baseline
Host Transcriptomic Response
Time Frame: From samples collected at baseline
RNA Sequencing from lesion and blood samples
From samples collected at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2017

Primary Completion (Actual)

July 30, 2019

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

October 11, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (Actual)

October 16, 2017

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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